Safe cannulation devices, methods, and systems

ABSTRACT

Methods and devices for use and handling of intravenous and/or subcutaneous needles, and, more particularly, to safety devices for shielding needles or other sharp articles or devices that present a safety hazard are disclosed. In an embodiment, a needle protective sheath can include a top wall, a bottom wall, and a pair of side walls joining the top and bottom walls. A finger shield extends from the top wall at a front opening of the sheath and is attached to the top wall by a hinge portion. The finger shield can be rotated about the hinge portion to block the front opening so as to secure a needle within the sheath.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. application Ser. No.16/439,747, filed on Jun. 13, 2019, which is a Divisional of U.S.application Ser. No. 14/763,808, filed Jul. 27, 2015, which is a U.S.national stage entry of International Application No. PCT/US2014/014256,filed Jan. 31, 2014, which claims the benefit of U.S. ProvisionalApplication No. 61/759,666, filed Feb. 1, 2013, all of which are herebyincorporated by reference in their entireties.

FIELD

The present disclosure relates generally to methods and devices for useand handling of intravenous and/or subcutaneous needles, and, moreparticularly, to safety devices for shielding a needles or other sharparticles or devices that present a safety hazard.

BACKGROUND

Needles and other sharp articles are widely used in hospitals and otherpatient care settings. A class of needles known as butterfly needles andassociated shield devices are described in U.S. Pat. Nos. 5,112,311;5,266,072; 5,433,703; 5,562,636; 5,562,637; 5,704,924; 5,772,638;5,951,529; and 6,595,965.

SUMMARY

Methods and devices for use and handling of intravenous and/orsubcutaneous needles, and, more particularly, to safety devices forshielding needles or other sharp articles or devices that present asafety hazard are disclosed. In an embodiment, a needle protectivesheath can include a top wall, a bottom wall, and a pair of side wallsjoining the top and bottom walls. A finger shield extends from the topwall at a front opening of the sheath and is attached to the top wall bya hinge portion. The finger shield can be rotated (or folded) about thehinge portion to block the front opening so as to secure a cannula ofthe needle within the sheath.

Objects and advantages of embodiments of the disclosed subject matterwill become apparent from the following description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

Embodiments will hereinafter be described with reference to theaccompanying drawings, which have not necessarily been drawn to scale.Where applicable, some features may not be illustrated to assist in theillustration and description of underlying features. Throughout thefigures, like reference numerals denote like elements.

FIG. 1 shows a butterfly needle for insertion into a patient access,according to embodiments of the disclosed subject matter.

FIG. 2A is an isometric view of a needle protective sheath for use witha butterfly needle, according to one or more embodiments of thedisclosed subject matter.

FIG. 2B is a side view of a needle protective sheath for use with abutterfly needle, according to one or more embodiments of the disclosedsubject matter.

FIGS. 3A to 3B show side views of a needle protective sheath with abutterfly needle therein in open and secured configurations,respectively, according to embodiments of the disclosed subject matter.

FIGS. 3C to 3D show side views of another needle protective sheath witha butterfly needle therein in open and secured configurations,respectively, according to embodiments of the disclosed subject matter.

FIGS. 4A to 4F illustrate use of a needle protective sheath, accordingto embodiments of the disclosed subject matter.

FIGS. 5A to 5B are isometric views of a needle protective sheath in openand secured configurations, respectively, according to embodiments ofthe disclosed subject matter.

FIGS. 6A to 6B are isometric and side views of another needle protectivesheath in open and secured configurations, respectively, according toembodiments of the disclosed subject matter.

FIGS. 7A to 7B are isometric views of a third needle protective sheathin open and secured configurations, respectively, according toembodiments of the disclosed subject matter.

FIGS. 8A to 8B are isometric and side views of a fourth needleprotective sheath in open and secured configurations, respectively,according to embodiments of the disclosed subject matter.

FIGS. 9A to 9B are isometric views of a fifth needle protective sheathin open and secured configurations, respectively, according toembodiments of the disclosed subject matter.

FIGS. 10A to 10B are isometric views of a sixth needle protective sheathin open and secured configurations, respectively, according toembodiments of the disclosed subject matter.

FIGS. 11A to 11H illustrate various views of a needle, needle protectivesheath, and related components and features according to embodiments ofthe disclosed subject matter.

FIGS. 12A to 12E illustrate needle, needle protective sheath, andrelated components and features, according to further embodiments of thedisclosed subject matter.

FIGS. 13A to 13C illustrate configurations in which wings of thebutterfly needle can pop off the hub when the needle cannula is drawninto the protective sheath, according to embodiments of the disclosedsubject matter.

FIGS. 14A to 14C illustrate configurations in which wings of thebutterfly needle can break or tear off the hub when the needle cannulais drawn into the protective sheath, according to embodiments of thedisclosed subject matter.

DETAILED DESCRIPTION

Butterfly needles can be used for transfusions, in particular for takinga blood sample, or for providing a treatment to a patient, such as adialysis treatment. In any of the embodiments, generally needles have ahub and a cannula and may include a tube with one or more connectors ata proximal end of the tube. The lumen of the cannula can be single ormultiple and each may be in fluid communication with a respective tube.The cannula is commonly made of metal with a sharp tip but can be ofother materials such as ceramic or plastic and may have a blunt tip asin a buttonhole needle. As the term is used here, needle can alsoencompass what many identify as a needle set which includes tubes,connectors, junctions, etc., for example, to facilitate the connectionof the cannula to fluid circuits.

Many needles are termed butterfly needles on account of a pair of wingsthat extend radially from a hub of the needle. FIG. 1 shows an exampleof a butterfly needle 100. The needle 100 includes a cannula 106 forpiercing the skin of a patient and for providing fluid communicationbetween an opening on the cannula 106 and tubing 108. The cannula 106may be of a single or multiple (e.g., dual) lumen type. Tubing 108 canconnect to other tubing, machines, or fluid receptacles, such as a bloodsample vacuum tube. Tubing 108 is connected to the cannula 106 by a hub104. Hub 104 has a pair of wings 102 which extend radially from the hub.By pressing the wings 102 together, handling of the needle 100 forinsertion into an access site of the patient is facilitated.Additionally or alternatively, the wings 102 can be taped to the patientto hold the needle 100 in position when inserted at the access site.Thus, the wings 102 are also referred to herein as taping wings.

In one or more embodiments of the disclosed subject matter, a needleprotective sheath 200, as shown in FIGS. 2A-2B, can fit over a needle100 to receive the needle after removal from a patient access. Thesheath 200 can have a top wall 202, a bottom wall 204, and a pair ofside walls 206. The walls can define a front opening 224 at one end ofthe sheath 200 and a rear opening 212 at the other end of the sheath200. The rear opening 212 can allow tubing 108 of the needle 100 to passtherethrough such that the sheath 200 can be coupled to the needle 100when inserted into the patient access.

Each of the side walls 206 can include a groove 208 that starts at thefront opening 224 and extends to a point removed from the rear opening212. The groove 208 may thus divide the sheath into an upper jaw 222(defined by the top wall 202 and upper portions of the side walls 206)and a lower jaw 220 (defined by the bottom wall 204 and lower portionsof the side walls 206). Optionally, a needle securing recess 210 may beprovided at an end of groove 208 remote from the front opening 224 forreceiving and retaining portions of wings 102 and/or hub 104 of theneedle 100. The sheath 200 can be sized and shaped such that the end ofcannula 106 of the needle 100 is completely contained in the sheath 200(i.e., within walls 202, 204, 206 and remote from the front opening224).

A finger shield 214 can extend from the top wall 202 at the frontopening 224. The finger shield 214 can have a finger contact surface215, for example, for applying pressure to a patient access duringremoval of the needle. The finger shield 214 can be attached to the topwall 202 by a hinge portion 216. A connection portion 213 may extendfrom a surface of the top wall 202. The finger shield 214 may alsocurved at an end 218 thereof, for example, to assist in applyingpressure during needle removal.

After removal from a patient access, the needle (at least the cannula106 and hub 105) may be drawn into the needle protective sheath toprotect patients, medical personnel and others from accidental exposure.In embodiments, the needle protective sheath can be advanced over theneedle to encase the needle by drawing the cannula into the sheath. Thesheath may allow the needle to be advanced during use. Among thedisclosed embodiments are needle protective sheaths with slots toaccommodate wings of winged needles. See, for example, U.S. Pat. No.5,951,529 entitled “Needle Protector Sheath,” which is incorporatedherein by reference in its entirety, for details of a needle protectivesheath and its use.

Despite the use of the needle protective sheath, it is possible that theneedle may be accidentally displaced from the sheath thereby exposingpatients, medical personnel, or others to accidental contact with thecannula 106. Moreover, while needle protective sheaths improve safety,some risk is posed if the needle is not fully retracted so that thecannula is completely shielded from potentially creating a puncture.Still further, risks are created by the possibility of a finger enteringthe end of the needle protective sheath to cause a puncture or scratch.Still further, there is a risk that tissue can inadvertently enter thefront opening of the protective sheath when the needle is retractedtherein. Accordingly, an end cap for the front opening of the needleprotective sheath may provide an additional layer of protection againstaccidental needle punctures. In particular, the finger shield (e.g.,shield 214 in FIGS. 2A-2B) can be rotated into contact with the walls ofthe protective sheath to serve as an end cap and effectively close offthe front opening after removal of the needle from the patient access.

Referring to FIGS. 3A-3B, a needle protective sheath 300 with a needleretracted therein is shown. The needle protective sheath 300 has anupper jaw 322 and a lower jaw 324 separated by slot 326. Slot 326 isconstructed to receive wings 102 of the needle therein as the needle isretracted into the sheath 300. Cannula 106 of the needle can beretracted into the sheath 300 by pulling on tubing 108, which extendsthrough rear opening 330, until it is fully contained within the sheath300, i.e., an end of the cannula 106 is displaced from the front opening328. Finger shield 308 is connected to the upper jaw 322 by a bendableconnection portion 306. The connection portion 306 can include, forexample, a transverse groove to form a hinge or have a junction line forbending weakness. Once the cannula 106 is fully retracted into theprotective sheath, finger shield 308 can be rotated about the connectionportion 306 into contact with edges of the walls of the sheath at thefront opening, thereby closing off the front opening and securing theneedle therein.

The needle protective sheath 320 can include one or more features tosecurely hold the finger shield to walls of the sheath to close thefront opening 328 once the needle is retracted therein. For example,referring to FIGS. 3C-3D, a needle protective sheath 320 can include afinger shield 334 attached to an upper jaw 322 of the sheath by abendable connection portion 332. The finger shield 334 can include aprotrusion 310 extending from a surface thereof that is received by areceptacle 304 on the bottom jaw 324. Alternatively or additionally, thebottom and/or side walls can include a protrusion or latch while thefinger shield includes an opening or receptacle for receiving theprotrusion or latch therein. The finger shield 334 can thus be held atthe front opening so as to secure the needle within the sheath.

An exemplary use of the needle protective sheath is illustrated in FIGS.4A-4F. The needle is inserted into a patient access, with the needleprotective sheath at a rear end of the needle. Tubing 108 of the needlepasses through the protective sheath. To remove the needle from thepatient access, the needle protective sheath is moved into positionadjacent the access site, as shown in FIG. 4B. Wings 102 of the needleproceed along the slot 208 between the upper jaw 222 and the lower jaw220. The finger shield 214 is disposed over the patient access site andused to apply pressure to the site. At FIG. 4C, the needle is removedfrom the access site by pulling on tubing 108, thereby retracting theneedle into the sheath. The needle wings 102 may be pulled intoengagement with a recess at a rear portion of slot 208 in order tosecure the needle in the protective sheath. The needle protective sheathcan then be pulled away from the patient access site while continuing toapply finger pressure to the access site by way of finger shield 214, asshown in FIGS. 4D-4E. Once displaced from the access site, the fingershield 214 may be rotated into engagement with the walls of the needleprotective sheath so as to close the front opening 224, thereby securingthe needle within the protective sheath.

Various mechanisms for engagement between the rotated finger shield andthe needle protective sheath walls at the front opening are possibleaccording to one or more contemplated embodiments. For example, FIGS.5A-5B show a needle protective sheath using a latch that grasps anopening. Finger shield 214 includes an opening 504 arranged to receive alatch 502 extending from bottom wall 204 at the front opening 224.Alternatively, the opening may be provided in a portion of the bottomand/or side walls while the latch is provided on the finger shield. Thefinger shield can have traction features to prevent, or at least reducethe risk of, slipping when being manipulated by a user. For example,multiple ridges can be provided in the surface of the finger shield 214,as illustrated in FIGS. 5A-5B.

The latch 502 may snap into the opening 504 to secure the finger shield214 at the opening 224. The latch 502 and opening 504 can be constructedso as to permanently secure the finger shield at the front opening,i.e., to prevent removal of the needle of the sheath. Alternatively, thelatch 502 may be configured to be displaced from the opening 504 byappropriate manipulation to allow removal of the finger shield away fromthe front opening.

In another embodiment, the finger shield 214 can include a femalesecuring receptacle 604 while the bottom wall 204 of the needleprotective sheath can include a male locking peg or protrusion 602, asshown in FIGS. 6A-6B. The female securing receptacle 604 can receive themale locking peg 602 to secure the finger shield 214 at the opening 224.The peg 602 and receptacle 604 may form a friction fit with each otherto reliably hold the two together. Alternatively or additionally, thereceptacle can be provided on the bottom and/or side walls while theprotrusion is provide on the finger shield. For example, a cylindricalprotrusion 804 can be provided on a surface of the finger shield forcoupling to a receptacle 802 at the bottom wall 204, as shown in FIGS.8A-8B.

In another embodiment, the upper jaw 222 can include latch arms 702 onside walls of the needle protective sheath, as shown in FIGS. 7A-7B. Theside wall latch arms 702 can be constructed to receive side portions 704of the finger shield 214. For example, the finger shield 214 may snapinto position and be held in place by the latch arms 702 at the frontopening 224. Alternatively or additionally, the latch arms can beprovided on the finger shield 214 for engaging portions of the sidewalls and/or bottom wall of the needle protective sheath. Alternativelyor additionally, the latch arms 702 can be provided on lower jaw 220 orportions of bottom wall 204.

In yet another embodiment, the walls of the needle protective sheath mayinteract with portions of the finger shield 214 to secure the fingershield 214 at the front opening 224. For example, the finger shield 214can have be sized and shaped to fit into the front opening 224, suchthat edge portions 904 of the finger shield 214 can interact with aninterior face 902 of the upper jaw 222 to form a friction fit thatretains the finger shield 214 in place at the front opening 224, asshown in FIGS. 9A-9B.

Alternatively or additionally, the finger shield 214 can be formed withone or more protrusions to fit into the front opening 224, as shown inFIGS. 10A-10B. Finger shield 214 can have an undersurface opening sealportion 1004 (i.e., first protrusion) constructed to fit into the frontopening 224 when the finger shield is rotated. In addition, fingershield 214 can have an undersurface protrusion 1006 (i.e., secondprotrusion) separated from the seal portion 1004 by a gap 1008. The gap1008 may be sized and shaped so as to receive bottom edge 1010 of thebottom jaw 204. Optionally, the seal portion 1004 may be sized andshaped to form a friction fit with one or more edges of the walls of theneedle protective sheath, for example, edges 1002 of the upper jaw 222.Alternatively or additionally, the seal portion 1004 and protrusion 1006can form a friction fit at the bottom edge 1010.

Of course, any of the features of the needle protective sheathsdescribed above or elsewhere herein may be altered or combined to formadditional embodiments of the needle protective sheath. For example, aneedle protective sheath may include more than one of the mechanismsdescribed with respect to FIGS. 3A-3D and 5A-10B for securing the fingershield in a closed position at the front opening of the needleprotective sheath.

FIGS. 11A to 11H illustrate a needle, needle sheath, and relatedcomponents and features according to embodiments of the disclosedsubject matter. Referring to FIG. 11A, a needle 1100 has a removablegrip portion (removable from the needle portion indicated at 1104), inthe present embodiment in the form of pair of wings, one of which isindicated at 1102. A tubing portion 1108 connects to one or more lumensof a cannula 1106, which may be of a single or multiple (e.g., dual)lumen type. The grip portion 1103 is shown FIG. 11B with the gripportion 1103 (shown in side and profile views) separated from the needleportion 1104. A pair of releasing elements 1130 may be gripped andsqueezed together to facilitate release of the grip portion 1103 fromthe needle portion 1104. An engagement portion 1110 of a needle hub 1107may be shaped to locate the grip portion 1103 when attached to the hubportion 1107, in the present case by snapping engagement. This locatesthe grip portion 1103 in the axial direction and helps to ensure it isnot accidentally shifted during use or placed at the incorrect part ofthe needle portion 1104.

FIGS. 11C, 11E, and 11F show the needle portion 1104 enclosed within aprotective sheath 1120. The protective sheath 1120 has a closeable cover1118 that seals the protective sheath 1120 at a distal end thereof. Theproximal end of the sheath 1120 is shaped to form a seal 1124 with aproximal portion 1116 of the needle portion 1104 when the latter isretracted into the sheath 1120. When the needle portion 1104 isretracted into the sheath 1120, the closeable cover 1118 can be closedand sealed. To allow the closeable cover 1118 to seal, a sealing portionsuch as a plug 1119 may be provided. The plug 1119 may be configuredalong with the needle portion 1104 and the sheath 1120 such that theplug pushes the needle portion proximal portion 1116 into sealingengagement with the sheath proximal end seal 1124. The sheath proximalend narrows progressively, as indicated for example at 1123 in FIG. 11F,so that pushing the closeable cover 1118 closed may force the needleportion proximal portion 1116 into a tight seal with the sheath proximalend seal 1124. The cross-sectional shape of the seal 1124 at the sheathproximal end may be formed to match that of the needle portion proximalportion 1116. The closeable cover 1118 may be attached by means of aliving hinge 1125. In embodiments, the seal 1124 has a circularcross-section. FIG. 11H shows an end view of the needle 1104 andinserted in the protective sheath 1120 (with the closeable cover 1118open) at the center.

A view of the needle 1100 disassembled (into needle portion 1104 andgrip portion 1103) is shown at 11B. The needle 1104 section left sideenclosed within the sheath 1120 with the sheath closeable cover 1118closed is shown at FIG. 11F. The needle 1104 section right side enclosedwithin the sheath 1120 with the sheath closeable cover 1118 open isshown at FIG. 11E. FIG. 11G shows the sheath 1120 with its inner walls1128 indicated in phantom. FIG. 11C shows the needle portion 1104 (afterthe grip portion 1103 has been detached) with the cannula 1106 sealedwithin the closed sheath 1120. In this configuration, any leakage fromthe needle portion 1104 is fully sealed within an interior volume of thesheath 1120 because the latter is sealed at both ends thereof with sealsformed at distal and proximal ends of the needle portion 1104.

FIG. 11D shows the needle 1100 extending out of the sheath 1120 with thesheath being held in alignment for receiving the needle portion 1104after the grip portion 1103 is removed. In use, a kit can be provided asshown in FIG. 11D, which includes the needle 1100 with the removablegrip portion 1103 installed on the needle portion 1104 and theprotective sheath 1120 held on the tubing 1108 by virtue of the latterbeing inserted through the open internal volume of the protective sheath1120. A channel for the tubing 1108 is defined because the sheath distalend is open and the proximal end is sealed by the needle proximalportion 1106 itself. Note that the cover 1118 can be provided with anextension on a side opposite a connection to the protective sheath 1120(e.g., living hinge 1125) which can be gripped by a user to hold theprotective sheath 1120 back as the needle portion 1104 is withdrawn intothe protective sheath 1120 after removal of the grip portion.

In a method, the following steps can be performed:

-   -   1. A needle 1100 is provided with a detachable grip portion        1103, needle portion 1104, and a connected protective sheath        1120, where the sheath is slidable along a tubing 1108 that        allows fluid to flow into one or more lumens of the needle 1100.        The protective sheath is sealable at both ends, optionally using        portions of the needle. The needle is extended or provided        extended from the sheath. The needle may have a sterile tip        guard enclosing it, as known in the art.    -   2. After removal of any optional tip guard, the needle is        inserted in a patient and used. The sheath remains connected at        the proximal end of the needle as shown in FIG. 11D. The grip        portion 1103 may be used in the fashion of, for example,        butterfly needles as known in the art.    -   3. Once the needle is to be extracted from the patient, the grip        portion 1103 may be removed, for example, by pinching the        releasing elements 1130 or by just prying the recess 1132 from        the engagement portion 1110.    -   4. If present, the extension portion of the cover (See an        example of an extension 1206 in a further embodiment illustrated        in FIGS. 12A to 12C and attending discussion) can be held while        the tubing 1108 is drawn proximally to pull the needle portion        1104 into the sheath 1120.    -   5. The needle portion 1104 or tubing 1108 is moved firmly to        seal the needle proximal portion 1116 in the sheath proximal        portion 1124 in order to make it possible to close the cover        1118 (e.g., finger shield). The cover 1118 is then closed,        thereby sealing the distal end of the protective sheath 1120 and        the proximal portion 1124 of the sheath 1120.

FIGS. 12A to 12E illustrate needle, needle protective sheath, andrelated components and features according to further embodiments of thedisclosed subject matter. A protective sheath 1204 has a proximal end1202 that forms a seal by means of a ridge 1224 of the protective sheath1204 that fits into a channel 1222 of a needle hub 1218 bounded byflanges 1220 and 1226 of the hub 1218. This creates a combination ofinterference- and frictional-engagement that forms a fluid-tight seal atthe proximal end 1202 of the protective sheath 1204. In alternativeembodiments, the ridge and channel may switch between the sheath 1204and hub 1218. The interference may also be such that the hub creates apalpable or audible indication of engagement to form the seal. The hub1218 may be bonded with an epoxy material or thermosetting material asindicated at 1217. Tubing 1201 may be frictionally connected to the hub1218 or attached according to any known methods. A cannula 1212 of theneedle fits into an internal volume 1231 of the protective sheath 1204.

A cover 1215 with an extension portion 1206 is integrally attached by aliving hinge 1232 to the protective sheath 1204. The cover 1215 also hasa plug shaped feature 1214 that fits into a distal opening 1216 of thesheath 1204 to seal it when the cover 1215 is closed. The cover 1215 mayhave a more flexible region 1207 at the base of the extension portion1206 so that when the cover 1215 is closed, the extension portion canyield when pressure is inadvertently applied to it which might otherwisecause the plug shaped feature 1214 to unseal. Also, the cover 1215 iscurved in a way that makes it less likely to catch on something, such asan article of clothing, which would cause it to open after being closed.The shape of the gap 1227 at the more flexible region 1207 wraps aroundthe edge 1229 of the distal opening 1216 helping to ensure the coverresists reopening after closure.

The needle with removable wing-type grip portion is shown at 1200 inFIG. 12D. The needle 1200 has a hub 1218, to which the grip portion isremovably attached, and a cannula 1212. The hub 1218 can slide out a gap1258 in the grip portion, which sliding may be facilitated by usingreleasing elements 1256 (which function as levers, as do releasingelements 1130 in FIGS. 11A-11B) to increase the open size of the gap1258. The releasing elements 1256 are pinched together which leveragesopen the gap 1258 to facilitates release and reattachment of the gripportion 1254.

The functional features of the present embodiments of FIGS. 12A to 12E,as should be immediately apparent, may be as described with reference tothe embodiments of FIGS. 11A through 11H including the method of use indescribed in the enumerated list above.

FIGS. 13A to 13C illustrate embodiments in which the wings areconfigured to pop off the hub when the needle is drawn into theprotective sheath. A hub 1310 is attached to a cannula 1312 to form aneedle 1300 which fits into a protective sheath 1306. The protectivesheath 1306 has an interior volume 1345 with a tapered portion 1344 atits distal end that forms a compression seal with a similarly taperedportion 1342 of the hub 1310. A tube 1304 is attached to the hub 1310.When the tube 1304 is pulled relative to the protective sheath 1306, thetapered portions 1344 and 1342 are wedged together to form a tight seal.A finger shield carries a plug portion 1350 (see FIG. 13C) that sealsthe distal end of the protective sheath 1306 when a user folds thefinger shield 1348 downwardly over the protective sheath 1306 afterdrawing the needle fully thereinto. Note that the features of theembodiment of FIG. 12C that provide a palpable click to confirm that theseal at the distal end has been properly formed can be incorporated inthe present embodiment or others disclosed herein.

The hub 1310 has wings 1308 that are held on the hub 1310 by a clip 1315that operates in the clip-on manner illustrated in, and discussed withreference to, FIGS. 11A-11B, 12D, and 12E, with clip-on engagementportions that form an interfering engagement between the wings 1308 andthe hub 1310. In the present embodiment, the gap 1311 of the clip 1315spreads apart when the sloping portion 1355 of the wings 1308 fit intoand engage notches 1302 of the protective sheath 1306. This generates alateral force directed as indicated by the arrows 1316, causing the clip1315 to spread and thereby the gap 1311 to open up to release the clip1315 and attached wings 1308 from the hub. This allows the hub 1310 andcannula 1312 to be drawn into the protective sheath 1306 and the fingershield 1348 folded to place the plug portion 1350 into opening 1357 ofthe protective sheath 1306.

Notches 1302 may be arrayed about the opening 1357 formed in the distalend of the protective sheath 1306. The notches 1302 are shown in thedistal end view of the protective sheath 1306 in FIG. 13C. The notches1302 may be sized and shaped so that when the wings 1308 are received inthem, their orientations and/or positions are controlled to ensure thatthe continued pulling of the tube 1304 causes the clip 1315 to expandthereby releasing the wings 1308 (together with the clip 1315). Thus thenotches 1302 may prevent the wings from slipping to the side under theseparating force 1316 caused by pulling the tube 1304.

FIGS. 14A to 14C illustrate embodiments in which the wings areconfigured to break or tear off the hub when the needle is drawn intothe sheath. The structures of the present embodiments can be identicalto the structure of the embodiment of FIGS. 13A through 13C except thatthe wings 1330 are configured to be broken or torn from the hub 1311.The wings 1330 can have an intermediate member 1337 that attaches thewings to the hub 1311 such that they are held by interfering engagementor adhesive. Alternatively, the wings 1330 may be integral to the hub1311. In any case, the wings 1330 may be attached to the intermediatemember 1337 or the hub 1311 by a web or weakened material indicated at1336 with a recess 1334 in FIG. 14C which may facilitate the breaking ortearing of the wing 1330 from the intermediate member 1337 or the hub1311 when the tube 1304 is pulled. FIG. 14B shows the wings 1330tilting, as indicated by the arrows 1360, down and away as the tube 1304is pulled. Once the wings 1330 are removed, this allows the hub 1311 andcannula 1312 to be drawn into the protective sheath 1306 and the fingershield 1348 folded to place the plug portion 1350 into opening 1357 ofthe protective sheath 1306 (see FIGS. 13A and 13C for correspondingstructure and reference numerals).

According to first embodiments thereof, a needle protective sheathcomprises a top wall, a bottom wall, and a pair of side walls joiningthe top and bottom walls. In first embodiments, the walls define frontand rear openings at opposite ends of the sheath. In first embodiments,each side wall has a slot therein extending from the front opening to apoint displaced from the rear opening. In first embodiments, each slotis constructed to receive a wing extending from a hub of a butterflyneedle as the needle is retracted into the needle protective sheaththrough the front opening. In first embodiments, the needle protectivesheath further comprises a finger shield extending from the top wall atthe front opening. In first embodiments, the finger shield is attachedto the top wall by a hinge portion and is constructed to rotate aboutthe hinge portion to block the front opening so as to secure thebutterfly needle within the sheath.

Any of the foregoing first embodiments may be varied to form additionalfirst embodiments in which the finger shield is constructed to rotateabout the hinge portion and to contact the side walls. Any of theforegoing first embodiments may be varied to form additional firstembodiments in which said contact between the finger shield and the sidewalls forms a friction fit. Any of the foregoing first embodiments maybe varied to form additional first embodiments in which the fingershield includes a first projection extending from a surface thereof, thefirst projection being constructed to fit into the front opening to forma friction fit between the first projection and the walls. Any of theforegoing first embodiments may be varied to form additional firstembodiments in which the finger shield includes first and secondprojections extending from a surface thereof, the first projection beingseparated from the second projection by a gap, the first projectionbeing constructed to fit into the front opening, the gap being sizedsuch that the bottom wall forms a friction fit with the first and secondprojections when a front edge of the bottom wall is disposed therein.Any of the foregoing first embodiments may be varied to form additionalfirst embodiments in which at least one of the side and bottom wallsincludes a latch for engaging with a portion of the finger shield. Anyof the foregoing first embodiments may be varied to form additionalfirst embodiments in which one of the bottom wall and the finger shieldincludes a latch portion or protrusion, and the other of the bottom walland the finger shield includes an opening or receptacle for receivingsaid latch portion or protrusion. Any of the foregoing first embodimentsmay be varied to form additional first embodiments in which each sidewall includes a latch arm for securing the finger shield against thefront opening.

According to second embodiments thereof, a cannulation device comprisesa needle having a hub and a cannula. In second embodiments, the hub hasa connection portion to which a grip portion is releasably attached. Insecond embodiments, the needle is connected to a tube. In secondembodiments, the cannulation device further comprises a sheath having achannel therethrough sized to permit the tube to run through the channeland allow the sheath to be slid therealong up to and over the cannula.In second embodiments, the sheath is configured such that it is openonly at proximal and distal ends thereof, the hub and sheath beingshaped to form a fluid-tight seal when the hub is retracted into theproximal end. In second embodiments, the sheath has a cover portionattached to the sheath that can be closed to seal an opening at thedistal end when the hub is retracted such that the cannula is fullyenclosed when the hub is retracted and the cover portion is closed.

Any of the foregoing second embodiments may be varied to form additionalsecond embodiments in which the cover portion is integral to the sheath.Any of the foregoing second embodiments may be varied to form additionalsecond embodiments in which the cover portion has an extension forming agrip at a part of the cover portion that is remote from a portion bywhich it is attached to the sheath. Any of the foregoing secondembodiments may be varied to form additional second embodiments in whichthe grip part has traction features to prevent slipping. Any of theforegoing second embodiments may be varied to form additional secondembodiments in which the traction features include multiple ridges. Anyof the foregoing second embodiments may be varied to form additionalsecond embodiments in which the hub has a sealing portion with a roundcross-section whose diameter is larger than said tube, said sealingportion forming said seal at said proximal end. Any of the foregoingsecond embodiments may be varied to form additional second embodimentsin which said sealing portion includes a channel which engages a ridgeof said sheath to provide a combination of an interference and frictionfit. Any of the foregoing second embodiments may be varied to formadditional second embodiments in which said sealing portion includes aridge which engages a channel of said sheath to provide a combination ofan interference and friction fit. Any of the foregoing secondembodiments may be varied to form additional second embodiments in whichthe hub and sheath are configured such that a making of said fluid-tightseal generates an audible or palpable signal.

According to third embodiments thereof, a cannulation device comprises aneedle having a hub and a cannula, the hub having a connection portionto which a grip portion is releasably attached. In third embodiments,the needle is connected to a tube. In third embodiments, the cannulationdevice further comprises a sheath having a channel therethrough sized topermit the tube to run through the channel and allow the sheath to beslid therealong up to and over the cannula. In third embodiments, thesheath is configured such that it is open only at proximal and distalends thereof, the hub and sheath being shaped to form a fluid-tight sealwhen the hub is retracted into the proximal end. In third embodiments,the sheath has a cover portion attachable to the sheath such as to sealan opening at the distal end when the hub is retracted such that thecannula is fully enclosed when the hub is retracted and the coverportion is closed.

Any of the foregoing third embodiments may be varied to form additionalthird embodiments in which the cover portion is integral to the sheath.Any of the foregoing third embodiments may be varied to form additionalthird embodiments in which the cover portion has an extension forming agrip at a part of the cover portion that is remote from a portion bywhich it is attached to the sheath. Any of the foregoing thirdembodiments may be varied to form additional third embodiments in whichthe grip part has traction features to prevent slipping. Any of theforegoing third embodiments may be varied to form additional thirdembodiments in which the traction features include multiple ridges. Anyof the foregoing third embodiments may be varied to form additionalthird embodiments in which the hub has a sealing portion with a roundcross-section whose diameter is larger than said tube, said sealingportion forming said seal at said proximal end. Any of the foregoingthird embodiments may be varied to form additional third embodiments inwhich said sealing portion includes a channel which engages a ridge ofsaid sheath to provide a combination of an interference and frictionfit. Any of the foregoing third embodiments may be varied to formadditional third embodiments in which said sealing portion includes aridge which engages a channel of said sheath to provide a combination ofan interference and friction fit. Any of the foregoing third embodimentsmay be varied to form additional third embodiments in which the hub andsheath are configured such that a making of said fluid-tight sealgenerates an audible or palpable signal.

According to fourth embodiments thereof, an access device comprises anaccess needle having a hub with detachable taping wings and a tubeextending from the hub. In fourth embodiments, the tube is in fluidcommunication with a lumen of the needle through the hub. In fourthembodiments, the access device further comprises a protective sheathdefining an inner enclosed volume with the tube slidably engagedtherewithin such that the needle and/or hub can extend from a distal endof the protective sheath enclosed volume and the tube can extend from aproximal end, opposite the distal end, of the protective sheath enclosedvolume. In fourth embodiments, the taping wings extend laterally awayfrom the hub and are wider than a distal opening of the enclosed volume.In fourth embodiments, the access device further comprises a fingershield, being a flat or substantially flat member, integrally attachedto and extending from a top side of the protective sheath distal end,the finger shield having an integral cover portion that closes over andcovers said distal opening.

Any of the foregoing fourth embodiments may be varied to form additionalfourth embodiments in which the cover portion has a first engagementportion and the protective sheath has a second engagement portion, thefirst and second engagement portions being configured to interferinglyengage to hold the cover portion over the distal opening when closedthereover. Any of the foregoing fourth embodiments may be varied to formadditional fourth embodiments in which the finger shield is flat in alateral aspect and curved in an aspect orthogonal to the lateral aspect.Any of the foregoing fourth embodiments may be varied to form additionalfourth embodiments in which the finger shield has ridges that areconfigured to engage the finger of a user when pressed by a user fingeragainst the body of a patient to permit the protective sheath to be heldin place against the body of the patient as the tube is drawn and theneedle and needle hub pulled into the enclosed volume. Any of theforegoing fourth embodiments may be varied to form additional fourthembodiments in which the finger shield has ridges that are configured toengage the finger of a user when pressed by a user finger against thebody of a patient to permit the protective sheath to be held in placeagainst the body of the patient as the tube is drawn and the needle andneedle hub pulled into the enclosed volume. Any of the foregoing fourthembodiments may be varied to form additional fourth embodiments in whichsaid finger shield is shaped with a concave surface facing away from alongitudinal axis of the protective sheath. Any of the foregoing fourthembodiments may be varied to form additional fourth embodiments in whichsaid finger shield is elongate with a lateral dimension that is smallerthan a lateral dimension of the protective sheath. Any of the foregoingfourth embodiments may be varied to form additional fourth embodimentsin which the protective sheath is generally cylindrical in shape. Any ofthe foregoing fourth embodiments may be varied to form additional fourthembodiments in which the integral cover portion and distal opening areshaped such that the cover portion can form a seal when it is closedthereover. Any of the foregoing fourth embodiments may be varied to formadditional fourth embodiments in which the integral cover portion anddistal opening are shaped such that the cover portion can form a seal,and the cover snaps into position due to interfering engagement uponforming a seal, when the finger shield is closed thereover. Any of theforegoing fourth embodiments may be varied to form additional fourthembodiments in which a living hinge is formed between the protectivesheath and the finger shield.

According to fifth embodiments thereof, an access device comprises anaccess needle having a hub and a cannula, the hub having detachabletaping wings and a tube extending from the hub. In fifth embodiments,the tube is in fluid communication with a lumen of the cannula throughthe hub. In fifth embodiments, the access device further comprises aprotective sheath defining a channel with the tube slidably engagedtherewithin such that the cannula and/or hub can extend from a distalend of the protective sheath channel and the tube can extend from aproximal end, opposite the distal end, of the protective sheath channel.In fifth embodiments, the taping wings extend laterally away from thehub and are wider than a distal opening of the channel. In fifthembodiments, the access device further comprises a finger shield, beinga flat member, integrally attached to and extending from a top side ofthe protective sheath distal end, the finger shield having an integralcover portion that closes over and covers said distal opening.

Any of the foregoing fifth embodiments may be varied to form additionalfifth embodiments in which the cover portion has a first engagementportion and the protective sheath has a second engagement portion, thefirst and second engagement portions being configured to interferinglyengage to hold the cover portion over the distal opening when closedthereover to form a palpable snap engagement. Any of the foregoing fifthembodiments may be varied to form additional fifth embodiments in whichthe finger shield is flat in a lateral aspect and curved in an aspectorthogonal to the lateral aspect so that it curves away from theprotective sheath longitudinal axis thereby to promote purchase of auser's finger when the protective sheath is pushed axially and the tubeis drawn axially in an opposite direction of the push. Any of theforegoing fifth embodiments may be varied to form additional fifthembodiments in which the finger shield has ridges that are configured toengage the finger of a user when pressed by a user finger against thebody of a patient to permit the protective sheath to be held in placeagainst the body of the patient as the tube is drawn and the needle andneedle hub pulled into the enclosed volume. Any of the foregoing fifthembodiments may be varied to form additional fifth embodiments in whichthe finger shield has ridges that are configured to engage the finger ofa user when pressed by a user finger against the body of a patient topermit the protective sheath to be held in place against the body of thepatient as the tube is drawn and the needle and needle hub pulled intothe enclosed volume. Any of the foregoing fifth embodiments may bevaried to form additional fifth embodiments in which said finger shieldis shaped with a concave surface facing away from a longitudinal axis ofthe protective sheath. Any of the foregoing fifth embodiments may bevaried to form additional fifth embodiments in which said finger shieldis elongate with a lateral dimension that is smaller than a lateraldimension of the protective sheath. Any of the foregoing fifthembodiments may be varied to form additional fifth embodiments in whichthe protective sheath is generally cylindrical in shape. Any of theforegoing fifth embodiments may be varied to form additional fifthembodiments in which the integral cover portion and distal opening areshaped such that the cover portion can form a seal when it is closedthereover. Any of the foregoing fifth embodiments may be varied to formadditional fifth embodiments in which the integral cover portion anddistal opening are shaped such that the cover portion can form a seal,and the cover snaps into position due to interfering engagement uponforming a seal, when the finger shield is closed thereover. Any of theforegoing fifth embodiments may be varied to form additional fifthembodiments in which a living hinge is formed between the protectivesheath and the finger shield. Any of the foregoing fifth embodiments maybe varied to form additional fifth embodiments in which the fingershield is positioned so that when the protective sheath is positionedsuch that the needle hub is drawn thereinto with the needle partiallyextending from the protective sheath, the finger shield partially coversthe needle such that as the needle is more fully drawn into theprotective sheath, pressure may be applied on top of the needle enters apatient access without coming in direct contact with the needle once itemerges from the patient access. Any of the foregoing fifth embodimentsmay be varied to form additional fifth embodiments in which the tapingwings are held on the hub by at least one of interfering and frictionalengagement between the taping wings and the hub. Any of the foregoingfifth embodiments may be varied to form additional fifth embodiments inwhich the taping wings are held on the hub by both interfering andfrictional engagement between the taping wings and the hub. Any of theforegoing fifth embodiments may be varied to form additional fifthembodiments in which the taping wings are held on the hub by interferingengagement between the taping wings and the hub. Any of the foregoingfifth embodiments may be varied to form additional fifth embodiments inwhich the taping wings are held on the hub by adhesive. Any of theforegoing fifth embodiments may be varied to form additional fifthembodiments in which the taping wings are held on the hub by a breakablebridge of material. Any of the foregoing fifth embodiments may be variedto form additional fifth embodiments in which the taping wings are heldon the hub by a tearable web of material. Any of the foregoing fifthembodiments may be varied to form additional fifth embodiments in whichthe taping wings are held on the hub by a tearable web of material witha notch facing a proximal end of the hub to facilitate tearing of theweb when the tube is pulled. Any of the foregoing fifth embodiments maybe varied to form additional fifth embodiments in which the taping wingsare held on the hub by a breakable bridge of material. Any of theforegoing fifth embodiments may be varied to form additional fifthembodiments in which the taping wings are held on the hub by a clampportion that is openable to release the taping wings by pinchingopposing tabs thereon.

According to sixth embodiments thereof, a method of cannulating apatient uses the device of any of the foregoing first through fifthembodiments. In sixth embodiments, the method comprises inserting aneedle into a patient, and moving the protective sheath over the hub toposition the finger shield over the point where the needle enters thepatient. In sixth embodiments, the method further comprises holding thefinger shield over the point where the needle enters the patient whilewithdrawing the cannula by pulling on a tube connected to the hub,thereby drawing the needle into the protective sheath, and folding thefinger shield over the end of the protective sheath until it snaps intoplace such that the needle is captured inside said protective sheath.

Any of the foregoing sixth embodiments may be varied to form additionalsixth embodiments in which the method further comprises supporting thefinger shield by a living hinge at a distal end of the protectivesheath. Any of the foregoing sixth embodiments may be varied to formadditional sixth embodiments in which the method further comprisesmanually removing the taping wings from the hub by squeezing a pinchingmechanism thereby to release an interference engagement of the tapingwings with the hub. Any of the foregoing sixth embodiments may be variedto form additional sixth embodiments in which the method furthercomprises pulling the tube such that the taping wings engage leveragingportions thereon that are effective, in response to the pulling, toweaken an engagement of the taping wings with the hub such that theeffect of the pulling is to cause the taping wings to be released,thereby allowing the needle to be drawn into the protective sheath.

According to seventh embodiments thereof, a method of cannulating apatient comprises inserting a needle with taping wings extending from ahub thereof into a patient and moving a protective sheath over the hubto position a finger shield over a point where the needle enters thepatient. In seventh embodiments, the method further comprises holdingthe finger shield over the point where the needle enters the patientwhile withdrawing a cannula of the needle by pulling on a tube connectedto the hub, thereby drawing the needle into the protective sheath, andfolding the finger shield over the end of the protective sheath until itsnaps into place such that the needle is captured inside said protectivesheath.

Any of the foregoing seventh embodiments may be varied to formadditional seventh embodiments in which the method further comprisessupporting the finger shield by a living hinge at a distal end of theprotective sheath. Any of the foregoing seventh embodiments may bevaried to form additional seventh embodiments in which the methodfurther comprises manually removing the taping wings from the hub bysqueezing a pinching mechanism thereby to release an interferenceengagement of the taping wings with the hub. Any of the foregoingseventh embodiments may be varied to form additional seventh embodimentsin which the method further comprises pulling the tube such that thetaping wings of hub engage leveraging portions thereon that areeffective, in response to the pulling, to weaken an engagement of thetaping wings with the hub such that the effect of the pulling is tocause the taping wings to be released, thereby allowing the needle to bedrawn into the protective sheath.

According to eighth embodiments thereof, an access device comprises anaccess needle having a hub, a cannula, and a flexible tube in fluidcommunication with a lumen of the cannula. In eighth embodiments, theaccess device further comprises a protective sheath defining a channelwith the tube slidably engaged therewithin such that the cannula and/orhub can extend from a distal end of the protective sheath channel andthe tube can extend from a proximal end, opposite the distal end, of theprotective sheath channel. In eighth embodiments, the access devicefurther comprises a finger shield, being a flat member, integrallyattached to and extending from a top side of the protective sheathdistal end. In eighth embodiments, the finger shield has an integralcover portion that closes over and covers said distal opening.

Any of the foregoing eighth embodiments may be varied to form additionaleighth embodiments in which the cover portion has a first engagementportion and the protective sheath has a second engagement portion, thefirst and second engagement portions being configured to interferinglyengage to hold the cover portion over the distal opening when closedthereover to form a palpable snap engagement. Any of the foregoingeighth embodiments may be varied to form additional eighth embodimentsin which the finger shield is flat in a lateral aspect and curved in anaspect orthogonal to the lateral aspect so that it curves away from theprotective sheath longitudinal axis. Any of the foregoing eighthembodiments may be varied to form additional eighth embodiments in whichthe finger shield has a traction portion that is configured to engage afinger of a user when pressed by the finger against the body of apatient to permit the protective sheath to be held in place against thebody of the patient as the tube is drawn and the cannula and needle hubare pulled into the enclosed volume. Any of the foregoing eighthembodiments may be varied to form additional eighth embodiments in whichthe finger shield has ridges that are configured to engage a finger of auser when pressed by the finger against the body of a patient to permitthe protective sheath to be held in place against the body of thepatient as the tube is drawn and the cannula and needle hub are pulledinto the enclosed volume. Any of the foregoing eighth embodiments may bevaried to form additional eighth embodiments in which said finger shieldis shaped with a concave surface facing away from a longitudinal axis ofthe protective sheath. Any of the foregoing eighth embodiments may bevaried to form additional eighth embodiments in which said finger shieldis elongate with a lateral dimension that is smaller than a lateraldimension of the protective sheath. Any of the foregoing eighthembodiments may be varied to form additional eighth embodiments in whichthe protective sheath is generally cylindrical in shape. Any of theforegoing eighth embodiments may be varied to form additional eighthembodiments in which the integral cover portion and distal opening areshaped such that the cover portion can form a seal when it is closedthereover. Any of the foregoing eighth embodiments may be varied to formadditional eighth embodiments in which the integral cover portion anddistal opening are shaped such that the cover portion can form a seal,and the cover snaps into position due to interfering engagement uponforming a seal, when the finger shield is closed thereover. Any of theforegoing eighth embodiments may be varied to form additional eighthembodiments in which a living hinge is formed between the protectivesheath and the finger shield. Any of the foregoing eighth embodimentsmay be varied to form additional eighth embodiments in which the fingershield is positioned so that when the needle hub is drawn into theprotective sheath with the cannula partially extending from theprotective sheath, the finger shield partially covers the cannula suchthat as the needle is more fully drawn into the protective sheath,pressure may be applied on top of a patient access without coming indirect contact with the cannula once it emerges from the patient access.

In any of the embodiments, alternative embodiments can be formed inwhich a cover may be provided as a separate element. In certainembodiments the cover may be provided as part of the grip portion, forexample by means of a plug formed in one or both wings of a suitablyconfigured grip portion.

In any of the embodiments having wings, such as taping wings, the wingsmay be removed, along with accommodations for them such as slots in thesides of a protective sheath, to form alternative embodiments. In any ofthe embodiments with wings, the wings and/or protective sheath may bemodified to permit the wings to fit into the protective sheath and anyslots in the side of the wings may be removed from the embodiment so asto form further embodiments. In any of the embodiments with wings, thewings and/or protective sheath may be modified to cause the wings tofold and fit into the protective sheath when the proximal tube is drawn(correspondingly any slots in the side of the wings may be removed) soas to form further embodiments. Any of the proximal seal mechanisms bywhich the needle hub seals with a protective sheath may be interchangedto form new embodiments.

Features of the disclosed embodiments may be combined, rearranged,omitted, etc., within the scope of the invention to produce additionalembodiments. Furthermore, certain features may sometimes be used toadvantage without a corresponding use of other features.

It is thus apparent that there is provided in accordance with thepresent disclosure, system, methods, and devices for safe cannulation.Many alternatives, modifications, and variations are enabled by thepresent disclosure. While specific embodiments have been shown anddescribed in detail to illustrate the application of the principles ofthe present invention, it will be understood that the invention may beembodied otherwise without departing from such principles. Accordingly,Applicants intend to embrace all such alternatives, modifications,equivalents, and variations that are within the spirit and scope of thepresent invention.

The invention claimed is:
 1. An access device, comprising: an accessneedle having a hub, a cannula, and a tube in fluid communication with alumen of the cannula; a protective sheath defining a channel with thetube slidably engaged in the channel such that the cannula and the hubcan extend from a distal end of the protective sheath and the tube canextend from a proximal end, opposite the distal end, of the protectivesheath; and a finger shield, being a flat member, integrally attached toand extending from a top side of the distal end of the protectivesheath, the finger shield having an integral cover that closes over andcovers an opening at the distal end of the protective sheath, whereinthe finger shield is flat in a lateral aspect and curved in an aspectorthogonal to the lateral aspect so that the finger shield curves awayfrom a longitudinal axis of the protective sheath, the finger shieldincludes at least a first undersurface protrusion configured to fit intothe channel of the protective sheath and a second undersurfaceprotrusion separated from the first undersurface protrusion by a gap,and the gap is sized and shaped to receive an edge of the distal end ofthe protective sheath.
 2. The access device of claim 1, wherein thefinger shield has a traction portion that is configured to engage afinger of a user when pressed by the finger against a body of a patientto permit the protective sheath to be held in place against the body ofthe patient as the tube is drawn and the cannula and needle hub arepulled into a volume enclosed by the protective sheath.
 3. The accessdevice of claim 1, wherein the finger shield has ridges that areconfigured to engage a finger of a user when pressed by the fingeragainst a body of a patient to permit the protective sheath to be heldin place against the body of the patient as the tube is drawn and thecannula and needle hub are pulled into a volume enclosed by theprotective sheath.
 4. The access device of claim 1, wherein the firstundersurface protrusion rises substantially perpendicularly away from anundersurface of the finger shield.
 5. The access device of claim 1,wherein the first undersurface protrusion has an outer perimeter thathas a shape that matches an inner perimeter of the channel of theprotective sheath.
 6. The access device of claim 1, wherein said fingershield is shaped with a concave surface facing away from thelongitudinal axis of the protective sheath.
 7. The access device ofclaim 1, wherein said finger shield is elongate and a lateral dimensionof the finger shield is smaller than a lateral dimension of theprotective sheath.
 8. The access device of claim 1, wherein theprotective sheath is cylindrical in shape.
 9. The access device of claim1, wherein the protective sheath has an oval cross-sectional shape. 10.The access device of claim 1, wherein the integral cover and the openingare shaped such that the integral cover forms a seal of the opening whenthe integral cover is closed over the opening.
 11. The access device ofclaim 1, wherein the integral cover and the opening are shaped such thatthe integral cover forms a seal, and the integral cover is held in aclosed position due to interfering engagement with an inner rim of theopening at the distal end upon forming the seal, when the finger shieldis closed over the opening.
 12. The access device of claim 1, wherein aliving hinge is formed between the protective sheath and the fingershield.
 13. The access device of claim 1, wherein the finger shield ispositioned so that when the access needle is drawn into the protectivesheath with the cannula partially extending from the protective sheath,the finger shield partially covers the cannula such that as the accessneedle is more fully drawn into the protective sheath, pressure may beapplied on top of a patient access without coming in direct contact withthe cannula once it emerges from the patient access.